Stakeholders Say FDA Must Change REMS Program

Standardization, a central database, and quick reporting are thought to improve safety

A recent survey of 28 organizations reveals widespread concern about many aspects of the REMS (risk evaluation and mitigation strategies) program, which is the FDA’s primary tool for proactively addressing specific safety concerns about new and existing medications. (See “Scope of REMS Programs” below.)

Scope of REMS programs

REMS programs may encompass any of three elements. The simplest is a communications plan that informs providers and patients about risks. A second element is expansion of risk and safety information in medication guides. The most complex component is elements to assure safe use (ETASU), with elaborate procedures to control distribution and register both patients and providers.

The FDA may require these elements in REMS programs

  • Expanded medication guides
  • Informed consent forms
  • Laboratory monitoring
  • Restricted distribution
  • Restricted prescribers
  • Specialized training
  • Specific ordering /inventory procedures
  • Patient registries
  • Prescription stickers

Source: American Pharmacists Association. White paper on designing a risk evaluation and mitigation strategies (REMS) system to optimize the balance of patient access, medication safety, and impact on the health care system. J Am Pharm Assn. Nov/Dec 2009. 49(6): 729-743

“Seventy-five percent of the participants felt the REMS program needs a major overhaul,” says Andrew Wilson, a senior research analyst at the Tufts University Center for the Study of Drug Development, which conducted the study.

Indeed, only 22 percent thought the REMS system had improved safety and 47 percent thought that compared to prior risk management programs, REMS had added cost and administrative burdens that outweigh its positive benefits. The survey included pharmacists, drug companies, health care providers, health plans, and patient advocacy organizations. It is not a landmark study because of the small numbers in each industry category, but it reveals that an array of pharma stakeholders agree about deficiencies in the REMS programs.

REMS and health plans

Lynn Nishida, RPh, director of pharmacy services at Regence, a group of Blue Cross Blue Shield plans, commented on her company’s view of REMS.

“The REMS programs for new medications can be improved,” says Nishida. “When we are evaluating a new drug we first look at its efficacy and then its safety. Often we don’t have any more safety information than was part of the initial clinical trials. Safety signals may start to emerge in clinical trials, and that is the reason a drug has a REMS. Then when a drug gets out into the public, additional safety information may start to emerge but we may never know about that. When we have safety concerns about a new medication we simply cannot make a well-informed decision about it.”

Nishida’s comment highlights a safety information gap that is inherent with REMS. The general timetable for assessment reports is after 18 months, 36 months, and seven years. Furthermore, the assessment reports pertain primarily to the goals of mitigating risk. So, currently REMS programs do not contribute much to health plans’ evaluations of new medications.

Reports on the effectiveness of REMS programs may be the weak link in the program.

“We haven’t seen any formal reporting of REMS programs; health plans would like to get that information,” says Nishida. Other industry experts comment that the FDA has not issued reports on the benefits and outcomes of the REMS initiative.

Nishida expressed other concerns. “REMS programs were not designed to totally limit a drug exactly to its approved use. There can be some variation in how prescribers use a drug, and there may be some risk associated with that variation.”

Nishida’s final comment deals with provider education and patient management. “What health plans would want in terms of provider education, especially for very risky medications, is a vetting of the doctors in all aspects of patient management including alternative medications.” In one case the FDA has taken a more direct approach: Limiting Avandia (rosiglitazone) to use only after failure of pioglitazone therapy.

What pharmacists want

Since the outset of the REMS program, pharmacists have been the most consistent and visible advocates for change.

A white paper from the American Pharmacists Association provides a detailed analysis of issues in the current program and describes many ways in which the program can be standardized to improve efficiency and effectiveness. The APhA calls for tiers where the scope and intensity of a program is tied to different levels of risk, more standardization of REMS procedures, and the establishment of centralized databases with uniform data requirements.

Recommended changes in the REMS program

A white paper from the American Pharmacists Association (APhA) outlines elements in REMS programs that could be standardized to improve both efficiency and effectiveness.

APhA recommendations for standardizing REMS programs
Recommendation Brief description
Balance standardization Balance drug risks against access and affordability considerations.
REMS levels Create tiers based on scope of REMS activities and type of risk.
Public education Create standardized content for patient education programs.
Individual patient education Include pharmacists in face-to-face and other education efforts.
Provider education Develop explicit provider education procedures.
Pilot testing REMS programs should be piloted before full implementation.
Data management Develop a workflow-integrated and centralized data management system.
Outcomes monitoring Develop drug-specific outcomes measures.
Quality of care Ensure that outcomes monitoring supports quality improvements.

Source: American Pharmacists Association. White paper on designing a risk evaluation and mitigation strategies (REMS) system to optimize the balance of patient access, medication safety, and impact on the health care system. J Am Pharm Assn. Nov/Dec 2009. 49(6): 729-743

“Standardization is a priority because there is some indication that REMS programs may be established for entire classes of drugs,” says David Chen, RPh, a section director at the American Society of Health-System Pharmacists. “Standardization will increase compliance.”

Standardization is also important, he says, because of the medications in the pipeline and because medications like epoetin alfa are used by many different specialists in different settings.

Pharmacists are also concerned about the workload created by the REMS programs that include elements to assure safe use (ETASU), which require the registration of providers and patients. “If a patient is admitted to a hospital, the registration documentation must be shared with the hospital to verify that the drug can be provided in the hospital. And we must verify registration of the physician who is prescribing the drug, because that doctor may be different from the patient’s regular prescriber,” says Chen.

Likelihood of change

Brian Meyers, director of government affairs at the American Society of Health-System Pharmacists, says the authority for REMS is in the Prescription Drug User Fee Act, which is up for re-authorization next year.

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“The REMS programs for new medications can be improved,” says Lynn Nishida, RPh, director of pharmacy services at Regence.

REMS draws its authority from the Prescription Drug User Fee Act says Brian Meyer, director of government affairs at the ASHP.


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